Analytical measuring device with lancing device

ABSTRACT

The invention concerns-a system for determining the presence or the content of an analyte in blood comprising a measuring instrument ( 1 ) for measuring and displaying the change of a characteristic property of a test element which correlates with the analyte and a lancing device ( 2 ) for obtaining blood from a body region of a test person, wherein the measuring instrument ( 1 ) and lancing device ( 2 ) are directly connected to one another in a detachable manner. In addition the invention concerns the use of such a system for determining the presence or the content of an analyte in blood.

CROSS-REFERENCE TO RELATED APPLICATIONS

This a 371 of PCT/EP98/07706 filed Nov. 30, 1998.

BACKGROUND OF THE INVENTION

The invention concerns a system and its use for determining the presenceor the content of an analyte in blood wherein the system comprises ameasuring instrument for measuring and displaying the change of acharacteristic property of a test element which correlates with theanalyte and it concerns a lancing device for obtaining blood from a bodyregion of a test person.

The determination of the content of a particular analyte in blood, forexample glucose or lactate, requires the collection of an adequateamount of sample (blood) and the provision of a suitable measuringsystem for the analyte. In addition to medical practices andlaboratories, medical laymen are increasingly carrying out suchdeterminations for their own use. Measuring systems that are designed tobe used by the test persons themselves are wide-spread especially forthe determination and monitoring of the blood sugar value i.e. the bloodglucose content in the case of diabetics and also to determine otherparameters such as the lactate content or cholesterol level.

Conventional measuring systems often contain test elements in the formof so-called test strips which, together with appropriate measuringinstruments, allow the determination of one or several analytes in theblood. In addition the user generally also requires a lancet which isused to pierce the skin of particular body regions for example of thefinger pad or earlobe and thus obtain blood which is to be used for themeasurement. Various manufacturers offer lancing devices for acomfortable blood collection which insert the lancets into the skin in acontrolled and guided manner in order to thus control the piercing depthand to minimize the pain.

Since the user requires several separate components (test elements,measuring instrument, lancing device, lancets etc.) in order to measurean analyte in blood and has to carry them with him for an outsideanalysis for example when travelling or for sport, it is understandablethat especially diabetics, which additionally have to carry insulin anda syringe, consider it desirable to reduce the individual componentsthat they have to have with them.

There have therefore been no lack of various attempts at reducing thenumber of individual components. One solution is to package thenecessary components such as measuring instrument, lancing device,lancets and test strips in a common transport case. However, these areoften voluminous and for example too large and too heavy to be kept in ajacket or shirt pocket.

Another solution is to integrate as many of the above-mentionedcomponents as possible into one instrument. An example of this is theintegration of a test strip storage system into a measuring instrumentas described in U.S. Pat. No. 5,489,414 or U.S. Pat. No. 5,645,798.

Systems in which the lancing device and measuring instrument have beenamalgamated into one instrument are described for example in U.S. Pat.No. 5,029,583 and U.S. Pat. No. 4,637,403. Although these integratedsystems essentially solve the problem of reducing the number ofindividual components that one has to carry, the handling of suchintegrated systems for blood collection is unsatisfactory since thesystems are usually cumbersome and comparatively heavy and thus make itdifficult to precisely aim at a lancing site.

The object of the present invention was to eliminate the disadvantagesof the prior art. In particular the aim was to find a system whichcombines the measuring instrument and lancing device and allows aprecise aiming at the lancing site with an overall reduction of thenumber of individual components that one has to carry.

SUMMARY OF THE INVENTION

The object is achieved by the subject matter of the invention ascharacterized in the patent claims.

The invention concerns a system for determining the presence or thecontent of an analyte in blood comprising a measuring instrument formeasuring and displaying the change of a characteristic property of atest element which correlates with the analyte and a lancing device forobtaining blood from a body region of a test person characterized inthat the measuring instrument and the lancing device are directlyconnected to one another in a detachable manner.

The invention also concerns the use of the system according to theinvention to determine the presence or the content of an analyte inblood.

Finally the invention concerns the individual components of the systemaccording to the invention i.e. a lancing device and a measuringinstrument that are suitable for a direct detachable connection to oneanother.

The system according to the invention is suitable for the determinationof the presence or the content of an analyte in blood. The determinationof the presence of an analyte can for example be used for thequalitative diagnosis of an infection (e.g. with viruses such as HIV orHCV) or for the qualitative determination of a particular state of thebody (e.g. pregnancy, cardiac infarction). The determination of thecontent of an analyte can be used to monitor the course of a disease orresponse to therapy and gives detailed information on the state of thebody of a test person. Examples of this are the measurement of the bloodglucose, the lactate or cholesterol concentration in the blood and suchlike. The system according to the invention preferably enables thedetermination of one parameter. The simultaneous determination ofseveral parameters is also possible in a further embodiment of thesystem according to the invention.

According to the invention the measuring instrument of the systemmeasures and displays the change of a characteristic property of a testelement that correlates with the analyte. The test element can bepresent in any form that is well-known to a person skilled in the artfor example in the form of a test strip or a cuvette where the reagentsrequired for the detection reaction are present in or on the testelement. When one or several analytes are present, the test elementenables the generation of a detectable signal as a characteristicproperty of the test element which correlates with the analyte. Examplesof this are colour changes in a detection reagent layer which can bemeasured photometrically, or electrical currents or changes in potentialwhich can be detected by electrode systems. The signals generated inthis manner are then measured and evaluated by the measuring instrumentby for example comparison with calibration values. Different detectionand determination methods are possible depending on the analyte to beexamined which differ in the physicochemical detection principle (e.g.photometry, electrochemistry) and, on the other hand, in thebio(chemical) interactions which lead to the characteristic, detectablechanges (e.g. detection by means of enzymatic or immunologicalreactions, nucleic acid sequence test).

In addition to the measuring instrument, the system according to theinvention contains a lancing device which can be used to obtain a bloodsample of a test person. Lancing devices are known for example to aperson skilled in the art from EP-B 0 565 970 and are sold commerciallyin different forms by various vendors. They are used in combination withlancets to obtain blood for example from the finger pad or the earlobein a comfortable, reproducible and painless manner.

In the claimed system the lancing device is connected according to theinvention with the measuring instrument in a direct and detachablemanner. Direct connection should be understood to mean that apart fromthe lancing device and the measuring instrument, no additional separatedevices such as pockets, covers, tapes or cases are necessary to connectthe lancing device and measuring instrument. In contrast the measuringinstrument or the lancing device or both components contain appropriateconnecting means which preferably match and fit one another and allow adetachable connection of the two components of the system. Possibleconnecting means are plug connections, clamp connections, connectionsusing profiled rails, connections by means of magnets or Velcrofastenings. The connection is preferably by means of plug connections inwhich case a connection with the aid of a clip is particularlypreferred.

The connection according to the invention between the lancing device andmeasuring instrument can be easily and rapidly detached and closed againand thus allows the system according to the invention to be handledcomfortably which makes it more acceptable to the users.

Since in a preferred embodiment of the invention it should be equallypossible to obtain blood of a test person by the lancing device in adetached state and also when connected to the measuring instrument, astable connection has proven to be particularly advantageous i.e. aconnection which resists the shear forces which are exerted on theconnection during operation of the lancing device. A connection with theaid of a clip is particularly preferred. Clips are known in variousshapes, materials and designs for example for writing utensils such asfountain pens, ball-point pens or felt-tip pens.

The clip is especially preferably attached to the lancing device whichespecially preferably has an essentially cylindrical, fountain-pen-likeshape as in EP-B 0 565 970 and the measuring instrument which preferablyessentially has the shape of a flat cuboid contains a recess with acorresponding shape particularly preferably on one of its narrow sidefaces which allows the clip to be held with an accurate fit and thusenables a stable, detachable and direct connection of the lancing deviceand measuring instrument. The clip and the corresponding recess to holdthe clip are preferably shaped such that when the stable connectingposition is reached, this is tactually or audibly discernible to theuser. The combination of the clip on the lancing device and anessentially complementary recess in the housing of the measuringinstrument enables an unequivocal, orientated and guided connection ofthe two system components according to the invention whereby the playbetween the lancing device and measuring instrument is optimized inorder to create a stable connection which resists shear forces and, onthe other hand, can be easily and rapidly detached. The lancing deviceparticularly preferably ends up essentially resting against the narrowside of the measuring instrument as a result of its connection with themeasuring instrument.

The lancing device and housing of the measuring instrument arepreferably designed such that a compact overall shape results. Forexample a recess in the shape of a trough which at least partiallyencloses the lancing device can be provided in the housing of themeasuring instrument. In addition to the compactness of the arrangement,this also additionally stabilizes the detachable connection between thelancing device and measuring instrument.

The clip for connecting the lancing device and measuring instrument canbe manufactured from the housing material of the lancing device or ofthe measuring instrument as well as from another suitable material.Suitable materials are for example metals, alloys or plastics orcombinations thereof e.g. plastic-coated metals or metallized plastics.The clip can be a component of the housing which is for examplemanufactured as an injection moulded part or it can be a separatecomponent which is, however, permanently connected to the housing.

It has also turned out that the lancing device and measuring instrumentcan be also advantageously connected by the shaping of the measuringinstrument housing. For example the measuring instrument can contain aflexible gripping jaw on one, preferably narrow side of the housingwhich partially encloses the lancing device and thus enables it to bedetachably attached to the measuring instrument. In this case it is notnecessary to attach devices to the lancing device to attach it to themeasuring instrument. In this preferred embodiment the means fordetachably connecting the lancing device and measuring instrument can bean integral component of the housing of the measuring instrument and canfor example be incorporated into it during the injection mouldingprocess. However, the said means can also be moulded as a separatecomponent that is, however, permanently connected to the housing.

The system according to the invention provides the user with a compactlancing device-measuring instrument system which reduces the number ofindividual components that the user needs to obtain blood andsubsequently measure a blood parameter. An additional advantage is thatthe user can decide whether he wants to use the lancing device connectedto the measuring instrument or detached from the measuring instrumentwhich enables a high degree of flexibility in operation. Moreover thelancing device can be cleaned safely and hygienically without a risk ofdamaging the measuring instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is elucidated in more detail by the following FIGS. 1 to5.

FIG. 1 shows schematically a top-view from above of a preferredembodiment of the system according to the invention.

FIG. 2 is a schematic top-view from direction A of the system accordingto the invention shown in FIG. 1.

FIG. 3 shows schematically the connecting mechanism for the lancingdevice and measuring instrument of the system according to the inventionof FIG. 1 on the basis of a partial sectional view.

FIG. 4 shows a preferred embodiment of the system according to theinvention as an alternative to FIGS. 1 to 3 based on three partialfigures (A to C).

FIG. 5 also shows a preferred embodiment of the system according to theinvention as an alternative to FIGS. 1 to 4 which is also based on threepartial figures (A to C).

The numbers in the figures denote:

1 measuring instrument

2 lancing device

3 display

4 operating element for the measuring instrument

5 operating element for the lancing device

6 connecting element 1 (clip)

7 connecting element 2 (complementary recess)

8 housing wall of the measuring instrument 1

9 clamping jaw

DESCRIPTION OF PREFERRED EMBODIMENTS

The system shown in FIGS. 1 to 3 which represents a particularlypreferred embodiment of the invention is composed of a measuringinstrument 1 and a lancing device 2 which are connected directly anddetachably to one another. In this case the lancing device 2 ends upresting essentially against the side of the measuring instrument 1.

The dimensions of the measuring instrument 1 are preferably such that itcan be held comfortably in one hand. The lancing device 2 hasessentially the shape of a fountain pen and its size (length, diameter)is essentially matched to the measuring instrument 1 in such a way thatno overhanging or protruding parts are present for the transport andoperation of the system.

The measuring instrument 1 contains all necessary functional componentsof which only the display 3 and an operating element 4 are shownschematically in FIGS. 1 and 3. The test elements which are to bemeasured with the measuring instrument 1 are inserted into theinstrument 1 from side A in FIG. 1 or, alternatively to instrument 1,can for example be provided by an integrated test element magazine.

The lancing device 2 also contains all necessary functional componentsof which only an operating element 5 is shown schematically. The lancetsfor obtaining blood are inserted into the lancing device 2 from side A(FIG. 1).

FIG. 3 shows a schematic detailed view of the connecting elements 1(clip) 6 and 2 (complementary recess) 7 for which a part of the upperside of the measuring instrument has been left out. The clip 6 fitsexactly into the complementary recess 7 which is formed by the wall ofthe housing 8 of the measuring instrument 1.

When using the lancing device 2 the operator will usually detach it fromthe measuring instrument 1 in order to collect blood as precisely andpainlessly as possible. For this purpose a corresponding lancet has tobe inserted into the lancing device 2, the lancing device 2 is activatedby for example tensioning a spring and is subsequently moved to thedesired body region such as a finger pad or earlobe from which it isintended to draw the blood. When the operating element 5 is actuated,the lancet pierces the desired body region and thus blood is obtained.

The blood is subsequently applied to the sample application region of atest element which is preferably already located in the measuringinstrument 1 and at least the sample application region of the testelement protrudes from the measuring instrument 1. The actualmeasurement is started by actuating the operating element 4. After thedetection reaction is completed on the test element the measured valueof the analyte determination appears in the display 3.

In the other preferred embodiment of the system according to theinvention shown in FIG. 4 which is composed of lancing device 2 andmeasuring instrument 1, the detachable connection between these twosystem components is also accomplished by a clip 6 on the lancing device2 and a corresponding complementary recess 7 on the measuring instrument1. The recess 7 is located in a side wall of the measuring instrumenthousing which matches the contours of the lancing device in order tostabilize the connection between the measuring instrument 1 and lancingdevice 2.

The top-view in FIG. 4A shows the locations of the measuring instrument1 and lancing device 2 in the connected state. FIG. 4B is a sectionthrough the plane of measuring instrument 1 and lancing device 2indicated by the arrows in FIG. 4A. This cross-section shows well howthe side wall of the measuring instrument housing matches the contour ofthe lancing device 2.

FIG. 4C illustrates how the lancing device 2 docks with the measuringinstrument 1. The lancing device 2 is orientated parallel to themeasuring instrument 1 with the clip 6 facing the side of the housingwhich contains the recess 7 that is complementary to the clip 6 and thelancing device is connected to the measuring instrument 1 by insertingthe clip 6 into the recess 7. Clip 6, recess 7 and the matching of theside wall of the measuring instrument 1 to the lancing device 2 ensurethat the connection is stable but can be detached again. The connectionis detached in the reverse sequence to making the connection.

FIG. 5 finally shows an alternative connecting mechanism for the lancingdevice 2 and measuring instrument 1. In this case the lancing device 2contains no special devices which allow a connection to the measuringinstrument but rather the connection is made by a special shape of oneof the side walls of the housing of the measuring instrument 1. Thiswall of the housing contains clamping jaws 9 which in the preferredembodiment of the lancing device 2 shown that has a round cross-section(FIG. 5B and C) partially surround it and hold it in such a way that itcan be readily detached. The material from which the jaws 9 are made ison the one hand flexible enough so that it can be pressed apart to holdthe lancing device 2 and on the other hand is stiff enough that it fixesthe lancing device 2 once it has been partially surrounded by the jaws 9and rests against the measuring instrument 1.

FIG. 5A shows in a top-view how the lancing device 2 approaches themeasuring instrument 1 and is held by the clamping jaws 9 on themeasuring instrument 1. A schematic section through the plane of themeasuring instrument 1 and lancing device 2 indicated by the arrows inFIG. 5A is shown in FIG. 5B. In this cross-section it can be readilyseen how the clamping jaws 9 are components of the housing wall of themeasuring instrument 1 which surround the lancing device 2. FIG. 5C islike FIG. 5B a schematic cross-section through the lancing device 2 andmeasuring instrument and in this case the arrows are intended toillustrate how the jaws 9 of the measuring instrument housing move apartwhen the lancing device 2 is inserted.

What is claimed is:
 1. A system for determining the presence or contentof an analyte in blood, the system comprising a photometric orelectrochemical measuring instrument for measuring and displaying thechange of a characteristic property of a test element which correlateswith the analyte, the measuring instrument being enclosed in aninstrument housing, and a lancing device, including an outer surface,for obtaining blood from a body region of a test person, wherein themeasuring instrument housing and the lancing device outer surface aredirectly and detachably connected to one another so that blood can beobtained from a body region of a test person with the aid of the lancingdevice when the lancing device outer surface is connected to themeasuring instrument housing as well as when the lancing device isdetached from the measuring instrument.
 2. The system of claim 1 whereinthe lancing device outer surface includes a protruding clip, and themeasuring instrument housing includes a corresponding recess adapted toreceive the clip.
 3. The system of claim 2 wherein the clip is anintegral component of the lancing device outer surface.
 4. The system ofclaim 2 wherein the clip is a separate component from the lancing deviceouter surface that is permanently fixed to the outer surface.
 5. Thesystem of claim 1 wherein a side of the measuring instrument housingincludes a trough, and the lancing device is detachably connected in thetrough on the side of the measuring instrument.
 6. The system of claim 5wherein the trough comprises a flexible gripping jaw for partiallyenclosing the lancing device.
 7. The system of claim 2 wherein theflexible gripping jaw is an integral component of the measuringinstrument housing.
 8. The system of claim 6 wherein the flexiblegripping jaw is a separate component from the measuring instrumenthousing that is permanently fixed to the measuring instrument housing.9. The system of any of claims 1-5 wherein the lancing device outersurface has a cylindrical, fountain pen-like form.
 10. The system ofclaim 1 further comprising apparatus on the measuring instrument housingand the lancing device outer surface which enable the measuringinstrument and the lancing device to be connected detachably.
 11. Thesystem of claim 1, 2 or 10 wherein said measuring instrument includes atleast one element for tactually or audibly indicating that a stableconnection has been achieved between the measuring instrument housingand the lancing device outer surface.
 12. The system of claim 1, 2 or 10wherein the measurement instrument housing at least partially enclosesthe lancing device when a stable connection has been achieved betweenthe measuring instrument housing and the lancing device outer surface.13. A lancing device suitable for use in the system of claim 1 whereinthe lancing device outer surface is designed such that the lancingdevice can directly and detachably connect to a measuring instrumenthousing for measuring and displaying the change of a characteristicproperty of a test element which correlates with the analyte.
 14. Ameasuring instrument suitable for use in the system of claim 1 whereinthe measuring instrument housing is designed such that the measuringinstrument housing can directly and detachably connect to a lancingdevice for obtaining blood from a body region of a test person.
 15. Asystem for determining the presence or content of an analyte in a bodyfluid, the system comprising a photometric or electrochemical measuringinstrument for measuring and displaying the change of a characteristicproperty of a test element subjected to the body fluid which correlateswith the analyte, the measuring instrument being enclosed in aninstrument housing, and a lancing device, including an outer surface,for obtaining the body fluid from a body region of a test person,wherein the measuring instrument housing and the lancing device outersurface are directly and detachably connected to one another, themeasurement instrument housing at least partially enclosing the lancingdevice and including at least one element for tactually or audiblyindicating that a stable connection has been achieved between themeasuring instrument housing and the lancing device outer surface. 16.The system of claim 15 wherein the lancing device outer surface includesa protruding clip, and the measuring instrument housing includes acorresponding recess adapted to receive the clip.
 17. The system ofclaim 16 wherein the lancing device outer surface defines a generallyelongated structure having a longest dimension in a longitudinaldirection, the protruding clip being received in the correspondingrecess by movement of the lancing device relative to the measuringinstrument housing in the longitudinal direction.
 18. The system ofclaim 15 wherein a side of the measuring instrument housing includes atrough, and the lancing device is detachably connected in the trough onthe side of the measuring instrument.
 19. The system of claim 16 whereinthe lancing device outer surface defines a generally elongated structurehaving a longest dimension in a longitudinal direction, the lancingdevice being received in the trough by movement of the lancing devicerelative to the measuring instrument housing in a direction normal tothe longitudinal direction.
 20. The system of any of claims 15-19wherein the lancing device outer surface has a cylindrical, fountainpen-like form.